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Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-BEYOND

Study acronym: TRACE-BEYOND
StatusRecruiting
PhasePhase 3
Started2025-05-30
View on ClinicalTrials.gov ↗

Amendment history

2026-03-27
minor
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v2
Eligibility criteria+209 characters
Inclusion Criteria: 1)Age ≥ 18 years old; 2)Acute ischemic stroke symptom onset between 24 to 72 hours p [...] essed stroke, onset time refers to 'last-seen normal time'; 3)Pre-stroke modified Rankin scale (mRS) score ≤1; 4)Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (both inclusive) or a score of 4 or 5 with a disabling deficit (e.g., hemianopia, aphasia, and loss of hand function); 5)Neuroimaging: Middle cerebral artery M1-M4 occlusion, ACA, PCA or M2basilar artery occlusion confirmed by CTA/MRA, middle cerebral artery M1 or M2 being responsible for signs and symptoms of acute [...] [...]
Secondary endpoints8 entries, revised
improvement on reperfusion at 24h after randomization (anterior circulation)
Study description+112 characters
Adult acute ischemic stroke patients due to large vessel occlusion (Middlemiddle cerebral artery M1-M4 occlusion, ACA, PCA or M2basilar artery occlusion confirmed by CTA/MRA) with baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 or a score of 4 or 5 with a disabling deficit (e.g., hemianopia, aphasia, and loss of hand function) will be enrolled in this trial. We use perfusion imaging to [...] CTP or MRI+PWI (ischemic core volume <70mL, mismatch ratio ≥>1.82, and mismatch volume ≥15mL>10 mL). We will randomly assign patients who have salvageable bra [...]
2025-11-17
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2025-04-24
minor
Original filing
3,268 trials monitored
See 122 trials at risk
The benefit-risk profile of thrombolysis for acute ischemic strokes beyond 24 hours has never been investigated. We initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled trial to assess the safety and efficacy of tenecteplase (0.25mg/kg, max 25mg) versus standard medical treatment in acute ischemic stroke due to intracranial vessel occlusion between 24-72 hours of symptom onset (including wake-up stroke and unwitnessed stroke).
Trial Details
NCT Number NCT06954155
Lead Sponsor Beijing Tiantan Hospital
Conditions Stroke
Enrollment 330 participants
Start Date 2025-05-30
Primary Completion 2027-02-28 (estimated)
Study Completion 2027-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-01